Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721

Summary

The purpose of this study was to evaluate the safety and tolerability of OMS721 (narsoplimab) in participants with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and Complement Component 3 Glomerulopathy (C3G) including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (NAb) of narsoplimab when administered intravenously and when administered both intravenously and subcutaneously in participants of Asian descent with IgA Nephropathy.

Timeline

Start

2016-03-10

Primary completion

2020-08-25

Completion

2020-08-25

Publications

• Background Lafayette RA, Rovin BH, Reich HN, Tumlin JA, Floege J, Barratt J. Safety, Tolerability and Efficacy of Narsoplimab, a Novel MASP-2 Inhibitor for the Treatment of IgA Nephropathy. Kidney Int Rep. 2020 Aug 13;5(11):2032-2041. doi: 10.1016/j.ekir.2020.08.003. eCollection 2020 Nov.

Drugs

Indications